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Osimertinib - AstraZeneca

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Drug Profile

Osimertinib - AstraZeneca

Alternative Names: [11C]AZD9291; [11C]osimertinib; ADAURA; AZD-9291; Mereletinib; TAGRISSO; Tagrisso

Latest Information Update: 27 Jan 2026

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At a glance

  • Originator AstraZeneca
  • Developer AstraZeneca; Avistone Pharmaceuticals; Dana-Farber Cancer Institute; Eli Lilly and Company; European Organisation for Research and Treatment of Cancer; European Thoracic Oncology Platform; G1 Therapeutics; Genprex; HUTCHMED; Incyte Corporation; Kyushu University; Molecular Partners AG; National Cancer Institute (USA); National University Hospital (Singapore); Princess Margaret Hospital (University of Toronto); Singapore Clinical Research Institute; Sunnybrook Health Sciences Centre; University of California at San Francisco
  • Class Acrylamides; Amides; Aniline compounds; Antineoplastics; Dimethylamines; Indoles; Phenyl ethers; Pyrimidines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase III Cancer; Meningeal carcinomatosis; Solid tumours
  • Phase II Adenocarcinoma; Glioblastoma

Most Recent Events

  • 09 Jan 2026 Sichuan Kelun-Biotech Biopharmaceutical plans a phase II trial for Non-small cell lung cancer (Combination therapy, First line therapy, Monotherapy, Neoadjuvant therapy) (IV, Infusion) in February 2026 (NCT07329322)
  • 28 Nov 2025 AstraZeneca completes the phase II AURA17 trial in Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater) in China (PO, Tablet) (NCT02442349)
  • 20 Nov 2025 AstraZeneca completes the phase III FLAURA trial in Non-small cell lung cancer (Late stage disease, First-line therapy) in USA, Canada, Hungary, Italy, Germany, Romania, France, Spain, Belgium, Netherland, Hong Kong, Poland, Russia, Ukraine, Thailand, Taiwan, South Korea, Japan, Turkey, Australia, Brazil, China, Israel, Sweden, Vietnam (NCT02296125)

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